NCT00520754

Brief Summary

Efficacy and Safety of Levocetirizine for Treatment of Recurrent Cough Associated With Other Allergic Symptoms in Children

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2001

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2007

Completed
Last Updated

December 12, 2013

Status Verified

September 1, 2009

Enrollment Period

1.2 years

First QC Date

August 24, 2007

Last Update Submit

December 11, 2013

Conditions

Cough

Keywords

levocetirizine dihydrochloride Xyzal tablets

Outcome Measures

Primary Outcomes (1)

  • The efficacy based on daily record cards recordings

    90 days

Secondary Outcomes (1)

  • Safety and pharmacokinetics at 90 days; skin reactivity

Interventions

levocetirizine dihydrochlorideDRUG

Eligibility Criteria

Age2 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • infants from 2 to 24 months both inclusive
  • suffering from recurrent cough associated with other allergic symptoms
  • hospitalized for respiratory or allergy related problems
  • laboratory results within normal ranges
  • height and weight between percentile 5 and 95

You may not qualify if:

  • having taken any of the disallowed medication
  • suffering form any disorder
  • history of sleep apnea
  • having concomitant chronic disease
  • known relevant renal, hepatic, cardiac or metabolism dysfunction
  • known alcohol or drug addiction, severe psychiatric disease for the parent/guardian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cranswick N, Turzikova J, Fuchs M, Hulhoven R. Levocetirizine in 1-2 year old children: pharmacokinetic and pharmacodynamic profile. Int J Clin Pharmacol Ther. 2005 Apr;43(4):172-7. doi: 10.5414/cpp43172.

    PMID: 15966463RESULT

MeSH Terms

Conditions

Cough

Interventions

levocetirizine

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • UCB Clinical Trial Call Center

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 24, 2007

First Posted

August 27, 2007

Study Start

December 1, 2001

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

December 12, 2013

Record last verified: 2009-09